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Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.

ABSTRACT: Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables. We created a structured overview showing the reporting frequencies of baseline characteristics and the prognostic relevance of identified variables. We used a modified Delphi panel of two rounds involving an international panel of 23 leading medical oncologists in the field of pancreatic cancer to develop a consensus on the various variables identified. In total, 39 randomised controlled trials that had data on 15?863 patients were included, of which 32 baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 23 baseline characteristics and 12 prognostic characteristics were designated as mandatory for future pancreatic cancer trials. The COnsensus statement on Mandatory Measurements in unresectable PAncreatic Cancer Trials (COMM-PACT) identifies a mandatory set of baseline and prognostic characteristics to allow adequate comparison of outcomes between pancreatic cancer studies.

SUBMITTER: Ter Veer E

PROVIDER: S-EPMC6863153 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.

Ter Veer Emil E van Rijssen L Bengt LB Besselink Marc G MG Mali Rosa M A RMA Berlin Jordan D JD Boeck Stefan S Bonnetain Franck F Chau Ian I Conroy Thierry T Van Cutsem Eric E Deplanque Gael G Friess Helmut H Glimelius Bengt B Goldstein David D Herrmann Richard R Labianca Roberto R Van Laethem Jean-Luc JL Macarulla Teresa T van der Meer Jonathan H M JHM Neoptolemos John P JP Okusaka Takuji T O'Reilly Eileen M EM Pelzer Uwe U Philip Philip A PA van der Poel Marcel J MJ Reni Michele M Scheithauer Werner W Siveke Jens T JT Verslype Chris C Busch Olivier R OR Wilmink Johanna W JW van Oijen Martijn G H MGH van Laarhoven Hanneke W M HWM

The Lancet. Oncology 20180301 3

Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatmen ...[more]

PMID: 29508762

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Project description:An American Hepato-Pancreato-Biliary Association (AHPBA)-sponsored consensus meeting of expert panellists met on 15 January 2014 to review current evidence on the management of intrahepatic cholangiocarcinoma (ICC) in order to establish practice guidelines and to agree on consensus statements. The treatment of ICC requires a coordinated, multidisciplinary approach to optimize survival. Biopsy is not necessary if the surgeon suspects ICC and is planning curative resection, although biopsy should be obtained before systemic or locoregional therapies are initiated. Assessment of resectability is best accomplished using cross-sectional imaging [computed tomography (CT) or magnetic resonance imaging (MRI)], but the role of positron emission tomography (PET) is unclear. Resectability in ICC is defined by the ability to completely remove the disease while leaving an adequate liver remnant. Extrahepatic disease, multiple bilobar or multicentric tumours, and lymph node metastases beyond the primary echelon are contraindications to resection. Regional lymphadenectomy should be considered a standard part of surgical therapy. In patients with high-risk features, the routine use of diagnostic laparoscopy is recommended. The preoperative diagnosis of combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC) by imaging studies is extremely difficult. Surgical resection remains the mainstay of treatment, but survival is worse than in HCC alone. There are no adequately powered, randomized Phase III trials that can provide definitive recommendations for adjuvant therapy for ICC. Patients with high-risk features (lymphovascular invasion, multicentricity or satellitosis, large tumours) should be encouraged to enrol in clinical trials and to consider adjuvant therapy. Cisplatin plus gemcitabine represents the standard-of-care, front-line systemic therapy for metastatic ICC. Genomic analyses of biliary cancers support the development of targeted therapeutic interventions.

Project description:BackgroundControversy exists regarding many aspects of decision making pertaining to same-day versus staged bilateral TKA (BTKAs), including patient selection, perioperative management decisions, and other important choices.Questions/purposesIn the absence of suitable randomized trials, we sought to determine areas of consensus among national experts on the following questions: (1) What are the comparative risks of same-day BTKAs compared with unilateral TKA (UTKA) and staged BTKAs? (2) Who should be considered an appropriate candidate for same-day BTKAs? (3) What constitutes appropriate workup and perioperative management for BTKAs? (4) What is the optimal time between procedures if same-day BTKAs are not deemed appropriate? (5) Are there orthopaedic or rehabilitation considerations for BTKAs that might outweigh medical contraindications?MethodsIn the setting of a consensus conference of national experts in orthopaedic surgery, anesthesiology, perioperative medicine, and epidemiology, the major questions surrounding same-day BTKAs were addressed by using an extensive literature review and the modified Delphi process. The process concluded with a meeting of participants and formulation of consensus statements.ResultsEighty-one percent of participants agreed that BTKAs are more invasive and complex procedures associated with increased risk for perioperative adverse events compared with UTKA in an unselected group of patients. The consensus group agreed that physicians and hospitals should consider using more restrictive patient selection criteria and exclude those with a modified cardiac risk index greater than 3 to mitigate the potentially increased risk. The majority of the group agreed that perioperative assessment and management should reflect the higher level of acuity of same-day BTKAs. Eighty-one percent of participants agreed that if a patient is not deemed a candidate for same-day BTKAs, a second TKA should be scheduled no sooner than 3 months after the first. The entire group agreed that when there is a conflict between the orthopaedic need and the medical adequacy of same-day BTKAs, the medical concern for the patient's safety should prevail over the orthopaedic need.ConclusionsExperts perceived that same-day BTKAs increase medical risk, and thus a systematic approach to the management of patients should be taken to minimize complications.

Dataset Information

Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.

Publications

Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease.

Similar Datasets

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